Preoperative IMRT for Soft Tissue Sarcoma of the Extremities and Trunk: Low Rate of Wound Complications

Terminated

• Conditions: Sarcoma
• Interventions: Radiation: Radiation

• Registration Number: NCT02785692
• Lead Sponsor: Balgrist University Hospital

Brief Summary

Postoperative wound healing complications following preoperative radiotherapy represent a severe problem in the treatment of malignant soft tissue tumors, and are reported to be 34% and more. The literature discusses intensely the advantages and disadvantages of this multimodal treatment concept and there are different opinions. The Canadian prospective randomized NCIC SR2 trial showed increased wound complication rates in the study arm receiving preoperative radiation. The Sarcoma Center Zurich pursues mainly this treatment concept and the results shall now be analysed and published. The approach is to show that not only the complication rates are comparable to international bench marks, but also the (still intermediate time) local control rates.

Detailed Description

Introduction: The Canadian prospective randomized NCIC SR2 trial tested the sequence of radiation and surgery for soft tissue sarcoma of the extremities. Similar disease control rates following pre- versus postoperative non-intensity modulated radiation therapy (non-IMRT) was found, with increased wound complications (17% vs 35%) in the preoperative radiation arm, \[95% CI 5-30\], p=0·01).

The investigators assessed a single center preoperative IMRT (or IMRT-equivalent highly conformal three dimensional conventional RT (3DcRT)) cohort with respect to the wound complication rate (WCR). The hypothesis was that a lower WCR rate was achieved in the era of IMRT as compared to the non-IMRT era when the Canadian Trial was conducted.

Methods: 67 consecutive patients irradiated with 50Gy in 25 fractions between 3/2008-3/2016 with preoperative IMRT (n=48, 72%) or highly conformal IMRT-equivalent 3DcRT dose distribution (n=19, 28%) were assessed. All patients were previously discussed at the weekly interdisciplinary sarcoma board of the Sarcoma Center Zurich.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-30
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-30
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Patients with a malignant soft tissue tumour
• Patients who underwent preoperative radiotherapy at the department of radiation oncology, University Hospital Zurich (USZ)
• Surgical treatment at Balgrist University Hospital between 2007 and 2016

Exclusion Criteria

• Vulnerability
• Previous chemotherapy
• Previous radiotherapy on the affected site
• Patient's wish

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Combined Radiation/ Surgery	Radiation	All patients treated with combined radiotherapy and surgery at Balgrist University Hospital and University Hospital Zurich

Primary Outcome Measures

Name	Time	Method
Major and minor wound healing complications	through study completion, minimum 6 weeks post surgery

Secondary Outcome Measures

Name	Time	Method
Local and metastatic disease control based on imaging such as CT scans and MRI	maximum 10 years post surgery
Overall survival at the latest point of follow- up	maximum 10 years post surgery

Trial Locations

Locations (2)

Balgrist University Hospital; 🇨🇭 Zurich, Switzerland

University Hospital; 🇨🇭 Zurich, Switzerland